Hormone Pregnancy Tests

Olivia Blake Excerpts

Thursday 7th September 2023 Commons Chamber

[Theresa Villiers (Chipping Barnet) (Con)]

I was moved and saddened to read of the lifelong health difficulties experienced by one of my constituents, whose mother was given the Primodos hormone pregnancy test. It is a story of school, work and family life disrupted over a period of decades, with frequent hospital visits, multiple operations, organ transplants, and a lifetime requirement to take a powerful concoction of immunosuppressants and other medication. I was hugely impressed and inspired to hear of this brave individual’s determination to succeed in life despite that adversity, and I believe it is time that he, and other Primodos victims, are finally given justice. I pay tribute to all the campaigners who have continued their fight for redress over all these years, despite so many setbacks.

The first warning of harm caused by hormone pregnancy tests came as early as 1958. Over the following period, many further problems were highlighted to the regulator of the time, the Committee on Safety of Medicines. As we have heard, the 1967 study by Dr Isabel Gal provided a clear warning of the serious damage being done by those tests, yet the sale of the product was not formally halted until 1978, 20 years after the first safety alerts, and 11 years after Dr Gal’s ground-breaking study. Since then, research has repeatedly indicated that taking the test increased the risk of children being born with debilitating and life-shortening birth defects such as damaged limbs, brain damage and heart problems.

A major review was conducted at the University of Oxford in 2018, led by the distinguished scientist Professor Carl Heneghan, director of the Centre for Evidence-Based Medicine. That study looked at 26 hormone pregnancy test studies involving over 76,000 women. The researchers concluded that taking drugs such as Primodos increased the risk of birth defects by 40%. They found “a clear association” between Primodos and several forms of malformation.

[Olivia Blake (Sheffield, Hallam) (Lab)]

I am a biomedical scientist by background, and having read that review, what I find important is the way the researchers interrogated all the subsequent research that had been done, to ensure that there was no bias in any of the studies they included, and they excluded any studies that they felt were biased, using stringent statistical analysis. That makes the review all the more important to listen to.

[Theresa Villiers]

I agree with the hon. Lady. It was a rigorous study, and it is a concern that in 2019 MHRA experts rejected that report, arguing that the quality of the studies examined was poor and the methods used to analyse them were

“not in line with best practice.”

As the hon. Lady pointed out, I do not think that is justified, and the Oxford team behind the research strongly refuted the claim made by the MHRA.

Despite all the scientific studies and research, campaigners have so far failed in their attempts to get compensation through the courts, and they have not been able to establish clear enough evidence of causation. That has been a massive hurdle in many cases over the years, not least in relation to tobacco, where it took decades of legal battles finally to show beyond doubt the causative link between smoking and cancer.

One of the problems faced by the families campaigning for compensation in this case is that many of the scientific studies of the ’70s and ’80s just do not meet the standards we necessarily expect in the 2020s. Many times in this House the call has come from Back Benchers loud and clear to support the families, to listen to their stories and to secure a fair outcome at last. The pressure that has come from this Chamber in so many debates helped to secure the welcome decision by the then Prime Minister, my right hon. Friend the Member for Maidenhead (Mrs May) to include Primodos in the independent medicines and medical devices safety review, led by Baroness Cumberlege.

Baroness Cumberlege concluded that Primodos was responsible for avoidable harm, that it continued to be used for years longer than it should have been, and that a fund should be set up to support families with the cost of care. She was very clear that, in the face of growing concerns, it should have been withdrawn from 1967. Her report acknowledges the disagreement between experts on whether Primodos caused birth defects, but she stated

“the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time. That should not have happened. This is not a case of us judging the actions of the past by the standards of today. This was discussed at the time, but not acted upon. The system failed.”

Those conclusions from Baroness Cumberlege are truly damning. We have a Government-sponsored independent review concluding that the system failed the victims and survivors of the Primodos tragedy. We must find a way to put that right and ensure that the families get the recognition and financial redress they deserve. I urge Ministers to listen to the House today and take action at last. We cannot let this injustice continue.